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Certifications & Workmanship Standards

Bioconnect is committed to meeting or exceeding these demanding quality standards to assure that all requirements for your custom application and those for all standard Bioconnect products are met.

·  FDA Registration # K010809

·  FDA 510K Approved Products

·  FDA CGMP Compliant

·  ANSI/AAMI EC-53-1995 Cable and Lead Standards

·  DIN 42-802

·  AAMI (EC-13, EC-53, EC-38)

·  Quality Assurance & Inspection certified to MIL-I-45208

·  Calibration Standards traceable to NIST

·  IPC/EIA J-STD-001 and IPC/WHMA-A-620 Standards